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Florida, where oxycodone caused 1,185 deaths in 2009, recently passed a “pill mill” law that tightens restrictions on pain clinics and physicians who prescribe pain medication.

In Washington, deaths from accidental overdose of opioid pain medications have surpassed automobile accidents as the leading cause of injury death among people 35 to 54 years of age. As a result, the state recently passed a law requiring careful assessment of how doctors manage chronic pain.

And Project Lazarus, based in Wilkes County, North Carolina, promotes the distribution of naloxone, an antidote that can save people who overdose on an opioid drug.

MOST DEATHS DUE TO MISUSE, NOT ABUSE

While illegal consumption of opioids is certainly growing, pain experts believe that most people who die from an overdose have a legitimate prescription for the pain killer. Perhaps they took too much in an effort to quell a sudden increase in their pain, or didn't realize that combining an opioid with alcohol, antidepressants, or sleep aids could cause them to stop breathing while they slept.

The actor Heath Ledger, for example, who died in January 2008, was found to have a lethal combination of prescription drugs in his system. On top of oxycodone and hydrocodone, he had taken diazepam and temazepam, which are often prescribed for anxiety and insomnia, the anti-anxiety drug alprazolam, and the antihistamine doxylamine, which causes drowsiness. As he slept his breathing grew increasingly shallow until it stopped.

“We call it waking up dead,” says Roger A. Rosenblatt, M.D., professor of family medicine at the University of Washington School of Medicine. “These people are not suicidal. They're just on a high dose of opioids, and they take some other medication or they have too much to drink, and the opioids cause respiratory depression.”

HIGHER DOSES MEAN HIGHER RISK OF OVERDOSE

Intense craving for opioids explains only a small part of the rapid increase in their use, according to pain experts. A more obvious explanation lies in the fact that chronic pain is a widespread problem affecting millions of Americans, and opioid drugs usually provide significant relief. Physicians are grateful to have such an effective tool at their disposal. Unfortunately, many apparently prescribe opioids without coaching patients sufficiently in the use of such drugs or monitoring how much patients are taking.

In 1986 Russell Portenoy, M.D., and Kathleen M. Foley, M.D., published a highly influential study, in the medical journal Pain, of 38 chronic pain patients who took opioids for several months without becoming addicted or developing significant side effects.

The pharmaceutical industry soon developed formulations that made opioids easier to use and marketed the new drugs aggressively. But what really drove the rapid increase in opioid prescriptions was their effectiveness.

“Drug companies were definitely part of the reason for the rapid increase in opioids for non-cancer pain,” says Dr. Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center, New York, NY. “But if there was no need, and the drugs didn't work, do you think doctors would keep prescribing them? Strong pain killers became more acceptable in the medical community because doctors have few other tools at their disposal, and they want to provide relief for their patients.”

Over time, people who start out on 30 or 40 milligrams of an opioid for chronic pain develop tolerance for the drugs and require larger doses. On the one hand, tolerance means a reduction in side effects such as constipation, nausea, and mental fogginess. Dr. Portenoy has a 56-year-old patient with chronic hip pain who is able to work and function normally on a very high dose of an opioid medication.

“If I gave him the same dose he's taking now when I first met him, I would have killed him after the first or second dose,” Dr. Portenoy says. “Now he takes that dose three times a day, and he's completely alert and able to do complex cognitive tasks on a daily basis.”

However, patients who take more than 100 milligrams a day of an opioid increase their risk of overdose by nine times, according to a 2010 study in the Annals of Internal Medicine.

“We have 10,000 people in Washington State now who are taking over 120 milligrams a day,” says Gary M. Franklin, M.D., a neurologist at the University of Washington who has done research on opioid prescribing. “This is how people get into trouble—as the dose creeps up, it's not always possible to monitor their intake. Higher doses put them at risk of depressed breathing—the leading cause of unintentional overdose—especially if they're taking other medications.”

OTHER RISKS OF OPIOIDS

The constipation produced by chronic opioid use got so bad for one man that he had to have his colon removed, Dr. Franklin says.

In addition, elderly people on opioids experience a higher rate of falls and fractures, according to a 2010 study in the Archives of Internal Medicine.

Pregnant women who take opioids risk giving birth to a baby addicted to the drug. “They get opioids from the mother in utero, so when they're born they start to get tremors as though they're coming off heroin,” says Dr. Franklin.

And since most opioids are mixed with acetaminophen, people who take them can develop liver damage, especially if they also start taking cold medications, sleep aids, Tylenol, or other products that also contain acetaminophen. That's why an FDA advisory panel recently recommended removing acetaminophen from opioid drugs.

“People on pain medication may not realize that another drug also contains acetaminophen, so they end up with liver failure,” says one member of the panel, Janet P. Engle, Pharm.D., a professor of pharmacy at the University of Illinois, Chicago.

Nevertheless, Dr. Engle voted against taking the acetaminophen out of opioid drugs. “I'm in favor of better education for prescribers and patients,” she says. “As long as the patient and the prescriber are careful that no more than 4 grams a day of acetaminophen is taken, these products are fine.”

While no one advocates eliminating opioids, many now recognize the importance of utilizing other forms of pain relief, such as cognitive behavior therapy, exercise, and physical therapy.

“These improve a person's perception of their pain,” says Dr. Franklin, “but most insurers do not pay for multidisciplinary pain care. We say opioids can be a problem, especially at high doses, but at same time we're not providing alternatives.”

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